Use of electronic health record data in clinical investigations - guidance for industry From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - Use of electronic health record data in clinical investigations – Guidance for industry. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Notice to industry: Medical devices contained in electronic health record (EHR) products From Health Canada 🇨🇦 This notice is for manufacturers of EHR software products and EHR-based medical devices. Through this notice, Health Canada wants to remind manufacturers of their regulatory obligations for EHR-based medical devices in Canada. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 31, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Access to Electronic Health Records by Sponsor representatives in clinical trials From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on September 8, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites